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Zalicus (Nasdaq: ZLCS), a biopharmaceutical company that
discovers and develops novel treatments for patients suffering from pain,
today announced top-line results from two Phase 2 clinical studies of Z160
in chronic pain indications. Z160 did not meet the primary endpoint in
either of the Phase 2 clinical studies in patients with lumbosacral
radiculopathy (LSR) and post-herpetic neuralgia (PHN). Z160 was shown to be
generally safe and well-tolerated with no drug-related serious adverse
events. Based on these results, Zalicus is discontinuing the Z160 program
and plans to focus efforts on Z944, its novel oral T-type calcium channel
modulator in development for the treatment of pain.
"Despite its promising preclinical profile, Z160 was unable to translate
those results into clinical efficacy. A review of the data demonstrate that
both studies were conducted in a rigorous fashion and resulted in adequate
exposure of Z160, yet failed to demonstrate a difference in effect from
placebo on any endpoint," said Mark H.N. Corrigan, MD, President and CEO of
Zalicus. "There is a significant unmet need for novel and effective
non-opioid based pain therapies, and it was our sincere hope that Z160, with
its novel mechanism of action, would offer the potential to provide relief
to the millions of patients who suffer from chronic neuropathic pain."
About Zalicus
Zalicus Inc. (Nasdaq Capital Market: ZLCS) is a biopharmaceutical company
that discovers and develops novel treatments for patients suffering from
pain. Zalicus has a portfolio of proprietary clinical-stage product
candidates targeting pain and has entered into multiple revenue-generating
collaborations with large pharmaceutical companies relating to other
products, product candidates and drug discovery technologies. Zalicus
applies its expertise in the discovery and development of selective ion
channel modulators and its combination high throughput screening
capabilities to discover innovative therapeutics for itself and its
collaborators in the areas of pain, inflammation, oncology and infectious
disease. To learn more about Zalicus, please visit www.zalicus.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 concerning Zalicus, its
product candidates Z160 and Z944, the Zalicus selective Ion channel
modulation technology and related preclinical product candidates and
Zalicus' other business plans. These forward-looking statements about future
expectations, plans, objectives and prospects of Zalicus and its product
candidates may be identified by words like "believe," "expect," "may,"
"will," "should," "seek," "plan" or "could" and similar expressions and
involve significant risks, uncertainties and assumptions, including risks
related to the development and regulatory approval of Zalicus' product
candidates, including risks relating to formulation and clinical development
of Z944, the ability of Zalicus to initiate and successfully complete
clinical trials of its product candidates, the unproven nature of the
Zalicus drug discovery technologies, the Company's ability to obtain
additional financing or funding for its research and development, and those
other risks that can be found in the "Risk Factors" section of Zalicus'
annual report on Form 10-K on file with the Securities and Exchange
Commission and the other reports that Zalicus periodically files with the
Securities and Exchange Commission. Actual results may differ materially
from those Zalicus contemplated by these forward-looking statements. These
forward-looking statements reflect management's current views and Zalicus
does not undertake to update any of these forward-looking statements to
reflect a change in its views or events or circumstances that occur after
the date of this release except as required by law.
(c) 2013 Zalicus Inc. All rights reserved.